Kornimate/medical-research-clean huggingface dataset:
treatment decision intervention for veterans with prostate cancer

Conditions: Prostate Cancer

Summary: newly diagnosed localized prostate cancer patients face difficult decisions about treatment and management; including radiation therapy, radical prostatectomy, brachytherapy, and observation. previous studies have cited patient preference and physician recommendation for treatment as major roles in treatment decisions.

background: newly diagnosed localized prostate cancer patients face difficult decisions about treatment and management; including radiation therapy, radical prostatectomy, brachytherapy, and observation. previous studies have cited patient preference and physician recommendation for treatment as major roles in treatment decisions. objectives: this grant will be used to develop and evaluate a decision analysis based intervention to improve decision-making among veterans with newly diagnosed localized prostate cancer. while the ultimate goal of this study is to improve decision-making among these patients, factors influencing physician recommendations for treatment will be sought. the former will be achieved by evaluating the efficacy of providing physicians with information incorporating patient preference for alternative health states with probabilities of treatment outcomes. factors influencing physician recommendations for treatment will be determined through qualitative interviews with physicians. methods: patients were accrued at the va chicago health care system lakeside urology clinic. upon consent for participation in the study, comorbidities, histologic grade of the biopsy, and age were obtained for 13 patients with newly diagnosed localized prostate cancer. using a standard gamble technique, interviewers obtained patient utilities for 5 distinct health states related to prostate cancer treatment. clinical and pathologic characteristics were incorporated into the decision analytic model, and the derived quality-adjusted life expectancies (qales) were shared with the treating urologist before patient-physician discussion of treatment options. the feasibility of the decision analytic intervention and unbiased estimates of the impact of the intervention was evaluated. the long-range objective of this proposal is to design an intervention for veterans that increases physician understanding of patient treatment preferences and patient understanding of choices in prostate cancer treatment. status: completed

Eligibility criteria:
inclusion criteria: 1) biopsy confirmed diagnosis of localized prostate cancer; 2) newly diagnosed-no prior treatment (including watchful waiting) or discussion with their prior physicians about treatment options; 3) no previous neoplasms in the last five years, with the exception of basal cell cancer of the skin; 4) speak english; 5) no major psychiatric disorder that would preclude their participation; 6) be between 50 and 80 years of age. exclusion criteria:
early exposure to omt prevents long los

Conditions: Prematurity

Summary: the application of osteopathic manipulative treatment (omt) in preterm infants has been demonstrated to be effective in reducing length of stay (los). the scope of the present study is to investigate the association between earlier exposure to omt and reduction of los in premature infants


Eligibility criteria:
inclusion criteria: * preterm infants born at age between 29 and 37 weeks * osteopathic treatment performed \< 14 days after birth * preterms born in the same hospital exclusion criteria: * gestational age \< 29 weeks * gestational age \> 37 weeks * first omt performed after 14 days from birth * genetic disorders * congenital disorders * cardiovascular abnormalities * proven or suspected necrotized enterocolitis with or without gastrointestinal perforation proven or suspected abdominal obstruction * pre/post surgery patients * pneumoperitoneum * atelectasis * newborn from an hiv seropositive/drug addicted mother * respiratory disorders * transferred to/from other hospital * admitted for preterminal comfort care (defined as neither intubation nor cardio-respiratory resuscitation)

Keywords: osteopathic manipulative treatment neonatology neonatal care prematurity complementary and alternative medicine length of stay
study comparing the pet scan and mri in identifying breast malignancies in women with breast abnormalities

Conditions: Breast Disease

Summary: this is a study looking at advanced imaging such as pet/ct and mri to see if they can provide a more accurate assessment of the patient with dense breasts or difficult to interpret mammograms. in addition, the ability to determine whether one or the other is more accurate or whether both together would be appropriate in this clinical situation, may be able to be measured. the mri studies are very sensitive for detection of breast histopathology but less specific in differentiating between small low grade malignancies are more benign pathologies. multifocal pathology can be challenging in determining site(s) for biopsy. pet scanning is specific in the measurement of metabolic glucose activity of various histopathologies and is accurate in differentiating aggressive from benign pathology in multifocal breast disease. a further drawback of pet is the lack of ability to observe lesions less than 3-4mm in diameter. in select cases the combination of mr and pet/ct is able to come to a more conclusive diagnosis - specifically with bilateral or multifocal breast disease.


Eligibility criteria:
inclusion criteria: * woman who have breast volumes allowing utilization of mri breast coil * patients who are considered, by radiologist reading the mammograms, to have non interpretable or difficult to interpret x-ray studies. these patients may or may not have palpable breast lumps and may and may not have suspicious areas on their x-ray mammograms. exclusion criteria: * women of child bearing potential not practicing a medically accepted method of birth control * women who are pregnant or breast-feeding

Keywords: radiology mri positron emission tomography breast abnormalities dense breast tissue
a dose escalation study of av-380 in cancer patients with cachexia

Conditions: Cachexia

Summary: this open label ascending dose study is designed to evaluate the safety, pharmacokinetics (pk), pharmacodynamics (pd), and immunogenicity of av-380 in cancer patients with cachexia. av-380 is an immunoglobulin (ig) g1 monoclonal antibody (mab) intended to bind circulating human growth differentiation factor 15 (gdf-15), a cytokine involved in cancer-induced cachexia.


Eligibility criteria:
inclusion criteria: 1. patient must be ≥ 18 years of age at the time of signing the informed consent. 2. patients with histologically confirmed solid tumor cancer who are actively receiving soc therapy for this cancer. 3. patients with cachexia as defined by fearon criteria: 1. weight loss \> 5% over past 6 months (in absence of simple starvation), or 2. bmi \ 2%, or 3. sarcopenia and any degree of weight loss \> 2% 4. patients with life expectancy ≥ 3 months exclusion criteria: 1. history of allergic or anaphylactic reaction to any monoclonal antibody (igg protein) or molecules made of components of monoclonal antibody 2. known brain metastases or cranial epidural disease unless adequately treated with radiotherapy and/or surgery (including radiosurgery) and stable for at least 2 weeks before first dose of study treatment. 3. myocardial infarction or heart failure of new york heart association grade 3-4 within 3 months prior to start of protocol therapy 4. uncontrolled pericardial effusion, or ascites requiring recurrent drainage procedures (once monthly or more frequently) 5. cachexia is caused by other reasons (e.g., severe chronic obstructive pulmonary disease, heart failure, or hiv/aids), or the patient has uncontrolled reversible causes of reduced oral food intake, including, but not limited to, oral mucositis, nausea/vomiting, diarrhea, and/or obstruction, impairing the patient's ability to eat as determined by the investigator. 6. patients receiving tube feedings or parenteral nutrition at the time of screening.
feasibility of intraoperative optical imaging and spectroscopy in brain tumors

Conditions: Brain Tumor

Summary: this clinical trial studies optical imaging in assessing activity during surgery in patients with brain tumors. new procedures, such as optical spectroscopy, may help doctors maximally remove brain tumors and minimize damage to normal brain.

primary objectives: i. to develop the instrumentation to achieve real time processing and display of intraoperative 2-dimensional optical imaging and spectroscopy (i2dos) maps in the operating arena. ii. to examine the timing and spatial involvement of human cortex intraoperatively to different stimuli using i2dos. outline: patients undergo i2dos.

Eligibility criteria:
inclusion criteria: * neurosurgical patient population in the city of hope brain and spinal tumor neurosurgical programs that have been diagnosed with a brain tumor. * only lucid patients qualified to consent to neurosurgical procedure will be approached for participation in this study. * we do intend to enroll subjects with potentially terminal brain tumors. due to the potential benefit of intraoperative mapping, we are not planning to exclude these subjects. * patients with any type of brain tumor will be eligible for participation. * all subjects must have the ability to understand and the willingness to sign a written informed consent. exclusion criteria: * there are no exclusion criteria except for individuals without a brain tumor and the location of the craniotomy. if the exposed area of brain is not compatible with peripheral stimuli or volitional activity the subject cannot be enrolled. * subjects, who in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study.

Keywords: brain tumor
a study of the efficacy and safety of 4 doses of imeglimin after 24 weeks of treatment in subjects with type 2 diabetes

Conditions: Type 2 Diabetes Mellitus

Summary: this study will assess the efficacy and safety/tolerability of 4 doses of imeglimin versus placebo. the study will be performed in subjects with type 2 diabetes either naive of treatment or previously treated with an oral monotherapy excluding thiazolidinedione.


Eligibility criteria:
inclusion criteria: 1. subject has given written informed consent 2. male and female type 2 diabetic subjects, either naïve of antidiabetic agents or treated with an oral anti-diabetic monotherapy. 3. body mass index (bmi) : ≥ 24 to ≤ 40 kg/m² 4. hba1c criteria: ≥ 7% and ≤ 9.5% 5. creatinine clearance ≥ 50 ml/\[min\*1.73 m2\] at screening visit 6. effective contraception for women of child bearing potential exclusion criteria: 1. any disease which in the investigator's opinion would exclude the subject from the study 2. acute cardiovascular event within 3 months before randomization 3. uncontrolled high blood pressure 4. impairment of hepatic function 5. history of drug-induced torsades de pointes or a marked baseline prolongation of the qtc interval 6. pregnancy or lactation 7. use of any non-permitted medication 8. positive screen for viral hepatitis
pilot trial of "my meal mate" (mmm), a smartphone application for weight loss

Conditions: Obesity; Overweight

Summary: the aim of this study is to implement an exploratory pilot trial of "my meal mate" (mmm), a smartphone application developed to facilitate weight loss, assessing its feasibility and acceptability. overweight and obese adults will be recruited from large employers within the local area. the trial will aim to recruit a sample size of 135 which is a pragmatic decision based on randomizing 45 people to each arm. participants will be randomized to one of three groups. the researchers have developed a smartphone application for weight loss called "my meal mate" (mmm) which incorporates a large branded food and drink database. mmm was developed using focus group data collected from potential system users and by benchmarking with similar commercially available diet tracking applications. one group will receive a smartphone with the mmm app downloaded on it, one group will receive access to an online food diary and one group will be given a paper food diary. participants will be asked to set a goal for weight loss and self-monitor their food intake and activity using their allocated study equipment. participants will be weighed at the beginning of the trial, at 6 weeks and at 6 months. feasibility and acceptability outcomes will be assessed.


Eligibility criteria:
inclusion criteria: * aged 18-65 * bmi equal to or greater than 27 kg/m2 * willing to commit the necessary time and effort to the study, * employed by a large employer in leeds (and expects to continue to be employed there for the next 12 months), * able to read and write in english, * able to access the internet, * willing to be randomised to one of three groups. exclusion criteria: * pregnant, planning a pregnancy within next 12 months, lactating * has had surgery for weight loss * taking the medication sertraline (due to associations with weight gain) * taking anti-obesity medications or medications for diabetes

Keywords: smartphone smartphone app smartphone application obesity overweight self monitoring
embrace-sc: observational study of subcutaneous (sc) tocilizumab alone or in combination with conventional disease-modifying antirheumatic drugs (cdmards) in rheumatoid arthritis

Conditions: Rheumatoid Arthritis

Summary: the purpose of this study is to evaluate the percentage of participants treated with subcutaneous (sc) tocilizumab who are still on treatment after 52 weeks and the factors that play a major role in continuation of treatment.


Eligibility criteria:
inclusion criteria: - aged \>/= 18 years of age with rheumatoid arthritis (ra) for whom the treating physician has made the decision to start subcutaneous (sc) tocilizumab (tcz) treatment according to approved label within 4 weeks prior to enrolment. exclusion criteria: * participants who have been receiving tocilizumab (tcz) for more than 4 weeks prior to enrolment. * participants who have received tcz in past treatments. * participants who have received treatment with any investigational agent within 4 weeks (or 5 half-lives of investigational agent, whichever is longer) of starting treatment tcz sc. * participants with a history of autoimmune disease or of any joint inflammatory disease other than rheumatoid arthritis (ra).
nano drug interventional therapy using digital subtraction angiography（dsa） for pancreatic carcinoma

Conditions: Pancreatic Cancer

Summary: the purpose of this study is to evaluate the safety and efficacy of nano drug interventional therapy using digital subtraction angiography（dsa） for pancreatic cancer. the nano drug is made by mixing gemzar® with compound glycyrrhizin injection.

by enrolling patients with pancreatic cancer adapted to enrolled criteria, this study will document for the first time the safety and the short and long term efficacy of nano drug interventional therapy using digital subtraction angiography（dsa）for pancreatic cancer.

Eligibility criteria:
inclusion criteria: 1. age:18-80 2. karnofsky performance status \>60 3. diagnosis of pancreatic cancer based on histology or the current accepted radiological measures. 4. classification tumor,nodes,metastasis-classification(tnm) stage: ⅱ,ⅲ,ⅳ 5. will receive interventional therapy 6. life expectancy: greater than 3 months 7. patients' routine blood test, liver function and kidney function have no obvious abnormalities 8. ability to understand the study protocol and a willingness to sign a written informed consent document exclusion criteria: 1. patients with other primary tumor except pancreatic cancer 2. history of coagulation disorders or anemia

Keywords: pancreatic cancer nano drug
research study looking at how well semaglutide works in people suffering from obesity and knee osteoarthritis

Conditions: Obesity

Summary: this study will look at participants body weight from the start to the end of the study. it will also look at how much pain participants have in participants knee from the start to the end of the study and how this affects participants daily life. this is to compare the effect on body weight and pain in the knee in people taking semaglutide with people taking "dummy" medicine. participants will either get semaglutide or "dummy" medicine. which treatment participants get is decided by chance. participants will need to take 1 injection once a week. the study medicine is injected with a thin needle in a skin fold in the stomach, thigh or upper arm. during the study, participants will have talks with study staff about how to eat healthy food and how to be more physically active. the study will last for about 1 ½ years. participants will have 14 clinic visits with the study staff. at the first clinic visit participants will have a blood sample taken. participants will have an x-ray of participants knee taken at the first visit. if participants have had an x-ray recently, this may not be needed. at 6 of the clinic visits participants cannot take pain medications for 3 days before the visit. participants cannot take part if participants have had a joint replacement surgery in participants knee. participants cannot take part if participants have or have had diabetes. women: women cannot take part if pregnant, breast-feeding or plan to become pregnant during the study period.


Eligibility criteria:
inclusion criteria: * male or female, age above or equal to 18 years at the time of signing informed consent * body mass index (bmi) equal to or greater than 30.0 kg/m\^2 * clinical diagnosis of knee oa (american college of rheumatology (acr) criteria) with moderate radiographic changes (kellgren-lawrence (kl) grades 2 or 3 as per central reading) in target knee. target knee joint is defined as most symptomatic knee at screening. if pain in knees are equal target knee joint will be in the most dominant leg. * pain due to knee oa exclusion criteria: * joint replacement in target knee * arthroscopy or injections into target knee within last 3 months prior to enrolment * any other joint disease in the target knee
exome evaluation in patients living with diabetes complicated by charcot neuroarthropathy.

Conditions: Type 2 Diabetes

Summary: diabetes, like obesity, has reached worldwide proportions such that we're talking about a pandemic. these two diseases are a major cause of mortality and multiple complications. the medical and financial stakes involved make these two diseases a major public health issue. two groups of factors contribute to these diseases: the environment and genetics. the use of next-generation sequencing (ngs) is a highly relevant tool for identifying mutations in already known genes, or new genes involved in the disease, for diagnostic purposes. this approach makes it possible to validate previously described genes and/or discover new loci linked to new signalling pathways involved in the pathophysiology of charcot's foot in patients with diabetes

in patients living with diabetes, a rare and devastating joint complication known as charcot's neuroarthropathy (cn) has been observed. the clinical presentation of this complication is characterized by activation of inflammation and bone remodeling markers, disruption of the osteoblast and osteoclast system, activation of the rankl (receptor activator of nuclear factor-kappa b ligand) system and its antagonist osteoprotegerin (opg), and often a fatigue fracture due to physical activity. the pathogenic mechanisms of cn have been the subject of much debate, and there are a number of competing theories which are not necessarily exclusive. cn patients have been shown to have reduced bone density in the lower limbs compared with neuropathic subjects. studies using bone markers to assess bone formation and resorption demonstrated that there is an increase in osteoclastic activity relative to osteoblastic activity in both acute and chronic forms of cn. in 2007, w.j. jeffcoate described cn as an increased inflammatory response to injury inducing increased bone lysis. since the emergence of this theory, a significant number of studies have evaluated inflammatory factors and bone modeling in patients with cn, such as c-reactive protein, tnf α and il6. three studies showed an increase in their levels in the setting of cn. otherwise known genes, or new genes implicated in the disease, for diagnostic purposes this approach makes it possible to validate previously described genes and/or discover new loci linked to new signalling pathways involved in the pathophysiology of charcot's foot in patients with diabetes.

Eligibility criteria:
inclusion criteria: * men or women aged 18 to 70 * with type 2 diabetes for at least one year * with active or chronic charcot neuroarthropathy (group 1) or * never had charcot neuroarthropathy (group 2) * have agreed to participate in the study and have signed an informed consent form. exclusion criteria: - subject under guardianship or curatorship.

Keywords: type 2 diabetes charcot neuroarthropathy exome
laser vs hyaluronic acid for gsm in breast cancer

Conditions: Urogenital Disease

Summary: all women from the outpatient department with a history of bc and gsm (genitourinary symptoms of menopause) symptoms will be invited to participate. after informed consent patients are either randomized to intravaginal laser or hyaluronic acid suppository treatment intravaginally, respectively. laser treatment will be performed twice, at baseline and after 1 month. the intravaginal hyaluronic acid suppository therapy will be applied daily during the first 10 days and then every third day until the three months follow-up. at baseline and three months follow-up the following questionnaires will be filled out (vas, (pgi-i, pgi-s, female sexual health questionnaire (eortc), baessler questionnaire, eortc quality of life questionnaire, zuf-8).

device i- laser the laser device is the juliet feminine laser to treat women with sui (stress urinary incontinence), gsm and vaginal laxity. asclepion' s headquarters are located in "asclepion laser technologies gmbh - brüsseler str. 10 - 07747 jena - germany". device ii- suppository the second device is a vaginal suppository called "cikatridina" manufactured by the company angelini to treat women with gsm. angelini pharma österreich gmbh's headquarters are located in brigittenauer lände 50-54, 1200 wien, austria.

Eligibility criteria:
inclusion criteria * genital symptoms of dryness/ burning/ irritation * and/ or lack of lubrication during sexual intercourse/ sexual discomfort or pain * and/or symptoms of urgency and dysuria or recurrent urinary tract infection * age 18-80 * history of bc and/ or dcis * completed locoregional therapy * current antihormonal therapy for bc possible * intravaginal treatment with creams/ suppositories other than study medicationshould be ceased during the trial exclusion criteria: * current or past genitourinary malignancy * abnormal pap smear * current genitourinary tract infection * abnormal uterine bleeding * photosensitive medication